On January 8, the FDA Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.
In 2022, CORE evaluated 65 incidents, responded to 28 and issued advisories for 11. These numbers show a slight increase from 2021 when 59 incidents were evaluated with 19 responses and 10 advisories. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy and fish.
CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert and a Consent Decree. Outbreak advisories were issued for:
E. coli O157:H7 linked to packaged salads
Cronobacter linked to infant formula
Salmonella Senftenberg linked to peanut butter
Hepatitis A Virus linked to strawberries
Unknown contaminant linked to French Lentil and Leek Crumbles
Listeria monocytogenes linked to ice cream
Listeria monocytogenes linked to Brie and Camembert soft cheese products
E. coli O121 linked to frozen falafel
Salmonella Litchfield linked to seafood
Listeria monocytogenes linked to enoki mushrooms
Salmonella Typhimurium linked to sprouts
The 2022 annual report highlights noteworthy outbreaks from 2022, including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe and Salmonella linked to peanut butter.
The FDA has provided an update on actions the agency has taken, and those underway, to strengthen the safety and resiliency of the supply of nutritious infant formula, including the release of a progress report specific to actions the agency has taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response. Actions taken include:
Hiring and providing specialized training to personnel dedicated to the oversight of critical foods, including infant formula. This includes setting up a dedicated critical foods inspectional cadre and establishing a new Office of Critical Foods. Both actions arm the FDA with resources and expertise that are focused solely on critical foods, and which facilitate enhanced oversight of these commodities.
Updating and improving the FDA’s infant formula compliance program, which outlines the agency’s inspectional and compliance approach to infant formula, to help ensure that infant formula products in the U.S. food supply are safe and nutritious.
Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, to better understand how these illnesses occur, spread, who is most at risk and what the FDA can do to prevent Cronobacter-related illnesses.
Increasing the diversity of infant formula available in the U.S., especially through the FDA’s transition plan for firms that had previously received a letter of enforcement discretion.
Updating and streamlining infant formula related materials on fda.gov to provide consumers, industry and medical professionals with more accessible information, including materials on Infant Formula and Cronobacter sakazakii and a new resource on handling infant formula safely (available in both English and Spanish).
Issuing warning letters to infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that manufacturers are producing infant formula under the safest conditions possible.
As we saw with the recent large scale recalls of infant formula, Cronobacter has become a pathogen of growing public health concern for vulnerable populations. Our guest experts, Sally Powell Price, Regulatory Expert Food and Beverage Safety at MilliporeSigma, and Andrew Lienau, Food Regulatory and Validation Senior Expert at MilliporeSigma, detail the importance of Cronobacter in food manufacturing, summarize detection solutions and provide a glimpse into the future of this potentially deadly pathogen.
Why is Cronobacter detection important?
Cronobacter are ubiquitous pathogens that have been isolated from a wide variety of sources including dried herbs and spices, soil, starches and milk products. They are found naturally in the environment, for example, in our yards, kitchens and living rooms. They even can live on surfaces including kitchen counters, sinks and food facility manufacturing equipment.
Andrew Lienau
Infant formula, as we have seen in recent years, can be contaminated by this type of bacteria. While Cronobacter infections are rare, they can be fatal to newborns and immunocompromised individuals. When these infections are diagnosed in infants, they are often linked to consumption of powdered formula.
According to CDC, the potential mortality rate for Cronobacter infection is 40%. It has high risks for newborns, especially low-birth weight infants. Cronobacter is highly resistant to stress and can survive in products such as powdered infant formula for more than two years, which is the major risk factor. Almost all Cronobacter species are linked to human infections (adults and infants).
How is MilliporeSigma’s Assurance® GDS method fit-for-purpose for detection of Cronobacter?
Ensuring an assay is robust is a lengthy process. Microbiology methods are reviewed and approved by standards or certification bodies. Certification organizations for food microbiology include AOAC International and Health Canada in North America and AFNOR Groupe and MicroVal in Europe. Approved testing methods undergo rigorous, systematic scientific scrutiny and validation to ensure they are credible and legally defensible and thus can be used with confidence by industry, regulatory agencies, research organizations, testing laboratories and academic institutions. It is important during this validation process to demonstrate that the methods are reproducible and provide consistent results across a variety of sites and users.
During the certification process, methods are compared against standard reference methods or a “gold standard.” For example, there is a reference method developed by ISO for enrichment of Cronobacter from foods. Through the certification process, the MilliporeSigma Assurance® GDS method performed as well as the reference method. But the GDS Cronobacter method requires less time, materials and personnel to obtain comparable results. This certification improves both industry confidence and access to a rapid, reliable method for detection of Cronobacter in food.
The GDS for Cronobacter method has been reviewed and approved by both MicroVal (MicroVal 2017LR77) and AOAC International (AOAC PTM 121903; AOAC OMA 2021.08). These review processes can take more than one year from initial submission of protocol to generation of the validation data, including final review of the results by the certification organization. Outside expert peers also review the method for approval.
This year MilliporeSigma was honored that the Assurance® GDS Cronobacter method was recognized as the Method of the Year Award in Microbiology by AOAC International.
What are the regulatory implications and outlook for Cronobacter & infant formula?
The recent move towards restructuring the FDA and Human Foods Program was in part driven by the high-profile recalls and subsequent infant formula shortages due to Cronobacter contamination. Over the next year, we can expect to see continued regulatory scrutiny of Cronobacter and similar pathogens or analytes that put infants and other vulnerable populations at risk.
Sally Powell Price
Last year, the U.S. FDA released a strategy to help prevent Cronobacter illnesses, and in 2023, they expanded their approach by increasing inspection capacity and updating the Infant Formula Compliance program.
Beginning in 2024, Cronobacter infection will be a nationally notifiable disease as recognized by the US Centers for Disease Control (CDC). The FDA will collaborate with states and public health labs to bolster testing efforts. This will provide more clinical isolates, complementing the FDA’s environmental and product sample collection and sequencing strategies. It will also increase sequencing data available in the NCBI database in hopes of bridging scientific gaps related to Cronobacter.
Furthermore, the FDA is reviewing existing testing criteria to potentially enhance finished product safety with a focus on infant formula regulations led by the Office of Critical Foods. The Agency is collaborating with Congress to explore legal avenues to require firms to report Cronobacter-positive product test results, among other requirements.
For infant formula manufacturers it’s not all about regulation, however. Manufacturers and stakeholders now have expanded opportunities for collaboration with the FDA and related working groups like the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). These partnerships offer a unique chance for productive dialogue and the potential to engage in valuable initiatives aimed at providing scientific insights into Cronobacter and its prevention, including elective surveillance programs. Additionally, stakeholders in the infant formula industry can strengthen efforts to be transparent with consumers. They may actively participate in public meetings and engage with industry associations such as the Association of Food and Drug Officials (AFDO) or The Partnership for Food Safety Education (PFSE), fostering open discussions and sharing best practices to enhance safety and quality standards in the production and preparation of powdered infant formula. This proactive engagement not only fosters consumer confidence but also contributes to a safer environment for infants and vulnerable populations.
The FDA has updated its infant formula compliance program for FDA investigators, laboratory analysts and compliance officers. The updates build on lessons learned over the last several years to elaborate on FDA’s approaches for inspections, sampling, laboratory analysis and imported infant formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities and instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the agency’s infant formula regulation.
The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, are also included in the updated compliance program.
Inspectors are directed to perform environmental sampling once a year at each domestic powder infant formula manufacturing facility during annual or compliance follow-up inspection for both Cronobacter and Salmonella analysis if there are no significant adverse supply-chain implications.
The Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination Team will prioritize the annual inspection schedule based on:
the facilities’ previous inspection results
number of consumer complaints since the last inspection
number of violative samples collected by FDA in the last twelve months
the previous environmental sampling results performed by FDA
Per the instructions, environmental sampling should focus on zone two sites near potential product exposure points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into drying system, filling lines, blending equipment, raw material handling equipment, etc.) including any areas indicating water accumulation. Additional sampling should also be done from zone three sites which may suggest a route of contamination (i.e., doorways, traffic routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites should not be swabbed as these zones can be hard to reach and may introduce contamination during swabbing of a closed system. Unless conditions observed indicate a possible route of contamination, FDA does not recommend swabbing zone four areas at a high frequency.
Inspectors are advised to collect between 100-300 environmental swabs for Cronobacter spp. and 100-300 environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility.
A new study, published in the Journal of Food Protection, found that spacing out samples over time, called “stratified” sampling, is better at catching risky pathogens like Cronobacter in powdered products, such as infant formula, than randomly sampling from the product as it is being produced. In addition, the study found that that while taking more samples of a product generally increases the chance of catching the pathogen, there is a point after which it is unlikely that additional sampling will increase safety.
All efforts were based on detecting a realistic hazard, here defined by testing samples from Cronobacter-contaminated batches produced in Europe in the 2010s, using the most current data available. The paper found that safety plans with 30 or more grab samples had a very high probability of detecting the hazard. And that there was a point of diminishing returns, such that very high sample numbers—for example, testing every can produced—would not be meaningfully more powerful.
“This shows that existing sampling and testing guidance is powerful, at least for the one hazard profile our team had access to for the study,” said project lead Matthew J. Stasiewicz of the University of Illinois Urbana-Champaign. “This also highlights the need for additional research and data-sharing efforts into patterns of contamination in current infant formula production, so that sampling and testing can be better matched to current needs.”
“In additional to analyzing scenarios we found relevant, we built a web app that allows industry stakeholders to simulate various sampling scenarios and gain deeper understanding of the effectiveness of sampling plans specific to their plants. With this knowledge, producers can proactively address risks and optimize current sampling practices,” added Minho Kim, lead author.
On March 8, the FDA sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our infants.
The agency notes that since the 2022 infant formula recalls and resulting shortages, it has been working to improve the resiliency of the infant formula supply by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate products in the U.S. marketplace through the exercise of enforcement discretion. The FDA has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacterprevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.
In addition, over the past two months, food safety staff have been meeting regularly with manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. The letter sent to manufacturers reflects the information the agency gained through interactions with industry as well as the latest available science on improving the microbiological safety of powdered infant formula.
The FDA called on members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.
NACMCF is an advisory committee, established by the USDA, that provides impartial, scientific advice and/or peer reviews to federal food safety agencies for use in the development of an integrated national food safety systems approach.
The meeting is intended to help the committee gain scientific insight regarding Cronobacter infections, including recommendations for how public health authorities can better protect public health, as well as recommendations for food safety management practices that the food industry can implement to enhance the safety of powdered infant formula.
The meeting will be held virtually using Zoom. Attendees must pre-register to receive a join link, dial-in number, access code and unique Attendee ID. Attendees who would like to deliver comments during the meeting must register by November 8, 2022. Attendees who do not plan to speak at the public meeting may register at any time up to the day of the meeting. The meeting agenda is available on the FSIS events page.
The U.S. Department of Health and Human Services, Office of the Inspector General (OIG) has announced an audit of the FDA over its actions regarding the Abbott infant formula recall. The audit, announced on June 2, will “determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”
The OIG is specifically examining the FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures related to conducting inspections of the manufacturing facility and overseeing Abbott’s initiation of the infant formula recall.
The FDA released a timeline of its infant formula-related activities, showing that inspectors first became aware of issues including standing water and inadequate handwashing during a routine inspection at Abbott Nutrition’s Sturgis, Michigan, facility in September 2021—the same month that the FDA received the first consumer complaint report of Cronobacter illness in an infant from the Minnesota Department of Health.
One key area of frustration during Congressional hearings in May was the delay of action on a whistleblower report filed with the FDA Detroit District Office in October 2021. The complaint was not reviewed by FDA leadership until February 2002, “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA.
Additional inspections of the facility between January and March 2022 found “significant, fundamental sanitation, building and equipment issues.” Swabs taken during the inspections revealed six confirmed samples of Cronobacter. These findings led Abbott, on the recommendation of the FDA, to voluntarily cease production at the facility and recall potentially contaminated products. The contaminated formula has been linked to four hospitalizations and two deaths.
The OIG audit is scheduled to be completed in 2023.
Last week, 3M Food Safety announced their 3M™ Molecular Detection Assay 2 – Cronobacter was designated by AOAC International as Performance Tested Method (Certificate #101703). The assay is compatible with their Molecular Detection System, which uses isothermal DNA amplification and bioluminescence detection to test for pathogens.
Cronobacter, a type of bacteria commonly found in powdered foods, supplements and baby formula, can survive for almost two years and exposure to an infant can be life-threatening.
“While less well known than other foodborne pathogens like Listeria or Salmonella, Cronobacter is no less dangerous – particularly because it preys on some of the most vulnerable populations,” says 3M Global Marketing Manager Carolina Riba. “It’s a point of pride for our team that the tests we’ve made for the dangerous pathogen were recognized by an organization like AOAC International.”
Using approved protocols set by the AOAC Research Institute, 3M’s testing process used an independent laboratory. They tested the assay on powdered infant formula, powdered infant cereal, lactose powder and an environmental surface.
3M has announced that its Molecular Detection Assay 2 has won the Gold Edison Award in the diagnostic tools category. The 2017 Edison Awards recognize innovators that have had a positive impact globally. The assay platform is a next-generation of tests, which also previously won an Edison award.
The technology is powered by isothermal DNA amplification and bioluminescience detection to provide a faster molecular detection of pathogens. Its single assay protocol enables batch processing of up to 96 different samples simultaneously and can provide same-day results.
The platform can be used to identify Salmonella, Listeria, Listeria monocytogenes, and E.coli O157 in food or environmental samples, and Cronobacter in powdered infant formula.
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